Full Press Release Details
Galectin TherapeuticsCorporate OverviewSeptember 2025
2 This presentation contains, in addition to historical information,
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance and use words such as "may," "estimate," "could," "expect" and
others. They are based on our current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements.These statements include those regarding potential
therapeutic benefits of our drugs, expectations, plans and timelines related to our clinical trials, supporting activities, potential partnering opportunities and estimated spending for 2025 and beyond. Factors that could cause our actual
performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not product positive data.Future phases or future clinical studies may not begin or
produce positive results in a timely fashion, if at all, and could prove time consuming and costly. Plans regarding development, approval and marketing of any of our drugs are subject to change at any time based on the changing needs of our
company as determined by management and regulatory agencies. Strategies and spending projections may change. We may be unsuccessful in developing partnerships with other companies or obtaining capital that would allow us to complete our
clinical trials or further develop and/or fund any future studies or trials.To date, we have incurred operating losses since our inception, and our future success may be impacted by our ability to manage costs and finance our continuing
operations. For a discussion of additional factors impacting our business, see our Annual Report on Form 10-K for the year ended December 31, 2024, and our subsequent filings with the SEC. You should not place undue reliance on
forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements. Forward-Looking Statements
Belapectin is a novel, potent, galectin-3 inhibitor with Fast Track
Designation Low toxicity as a carbohydrate-based molecule which is degraded by natural processes Patent protection through 2032 Only company to exclusively focus on treatment for MASH cirrhosis and portal hypertension Significant
efficacy observed in cirrhotic patients without varices Promising NAVIGATE results at 18 month read out, 40% reduction in new varices vs placebo in ITT; significantly lower incidence of new varices in per protocol population Encouraging
clinical response in difficult-to-treat cancers in combination with checkpoint inhibitor IND filed and approval to proceed received from FDA (Head & Neck cancer) Developing galectin-based therapeutics to improve the lives of patients
with chronic liver diseases and cancer Focused Pipeline MASH Cirrhosis Oncology (Combination Therapy) Investment Highlights 3
Highly Experienced Leadership Team 4 Over 32 years of public and private
company experience including more than a decade of audit, tax and SEC registrant experience with a major accounting firm. JACK W. CALLICUTT Chief Financial Officer Over 28 years of experience working in the pharmaceutical industry in
clinical data and trial management with 23 years as statistician. SETH ZUCKERMANSenior Director, Biostatistics Over 25 years diverse experience in the pharmaceutical research industry supporting global study operations from site to
personnel management. JESSICA KOPACZEWSKI Senior Director, Clinical Operations Highly experienced in pharmaceutical development of novel formulations and medicines with advanced manufacturing techniques and bringing them to
approval. JEFF KATSTRA VP, CMC / Pharmaceutical Development Extensive experience in clinical pharmacology, drug metabolism, and pharmacokinetics with various drug formats and across therapeutic areas, leading to 10 different global drug
approvals. EZRA LOWE, Ph.D. VP, Clinical and Preclinical Pharmacology Financial executive with over 25 years of management experience in a taxation, restructuring, acquisition, and private equity ventures. JOEL LEWIS Chief Executive
Officer & President Have two decades of expereince leading drug development across various stages of clinical trials in the pharmaceutical industry. Led multiple new drug application filings and secured approvals from several regulatory
agencies. KHURRAM JAMIL, M.D.Chief Medical Officer
Clinical Program Development
Stage Drug Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Fibrosis Belapectin MASH Cirrhosis and Portal Hypertension Cancer Immunotherapy (Combination therapy) Belapectin + Keytruda Melanoma + Head / Neck Cancer Oral
Galectin-3 Inhibitors Discovery program to identify subcutaneous forms of carbohydrates and oral small molecules 5 Laser-Focused Pipeline
Galectin 3 is part of the galectin family of sugar-binding proteins that act as
a "molecular glue", it is: Predominantly produced by activated macrophages Involved in a wide number of biological and pathological processes Galectin-3 recruits macrophages to injury sites and promotes chronic inflammation by activating
proinflammatory pathways 1. Marino KV, et al. Nat Rev Drug Discov. 2023;22(4):295-316. 2. Henderson NC, et al. Proc Natl Acad Sci U S A. 2006;103(13):5060-5. Galectin-3 drives many pathophysiological process in fibrotic diseases and
cancer 6 Galectin-3 is a Promising Therapeutic Target in Inflammatory and Fibrotic Diseases1,2 Proliferation Inflammation Fibrosis Apoptosis Adhesion Angiogenesis Metastasis Tumor Growth Differentiation Migration Galectin-3
Belapectin: a Proprietary Galectin-3 Inhibitor with Low Toxicity and
Anti-fibrotic Activity Belapectin is a polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars Belapectin Preclinical Data: In animal models of MASH (streptozotocin High-Fat
Diet mice1) and cirrhosis (thioacetamide treated rats2) belapectin was associated with decreased: Galectin-3 staining and galectin-3 expression in macrophages NAFLD Activity Scores Collagen-1 expression Hepatic collagen
deposition Hepatic fibrosis Portal pressure In toxicology studies, including monkeys, belapectin: Was well-tolerated even at high doses Accumulated in macrophages with a residence time longer than in plasma 1. Traber PG, et al. PLoS
One. 2013;8(12):e83481. 2. Traber PG, et al. PLoS One. 2013; ;8(10):e75361. 7
MASH Cirrhosis Represents a Significant Market Opportunity in the U.S. with No
FDA-Approved Treatment Metabolic dysfunction-associated steatohepatitis (MASH), previously known as non-alcoholic steatohepatitis (NASH), is characterized by fat accumulation, inflammation and fibrosis of the liver1 3%-5% of the global
population is estimated to be affected by MASH, though the disease is considered to be underdiagnosed2 There are genetic predisposition to MASH, yet certain health conditions put patients at increased risk:3 1. Fatty Liver Foundation.
https://www.fattyliverfoundation.org/#gsc.tab=0. .2. Sherif ZA, et al. Dig Dis Sci. 2016;61(5):1214-25. 3. NIDDK. NAFLD and MASH. https://www.niddk.nih.gov/health-information/liver-disease/nafld-nash/symptoms-causes. 4. Datamonitor
Healthcare. MASH Disease Analysis. 5. Scientific Registry of Transplant Recipients. OPTN/SRTR 2021 Annual Data Report: Liver. https://srtr.transplant.hrsa.gov/annual_reports/2021/Liver.aspx. 6. Stepanova M, et al. Hepatol Commun.
2022;6(7):1506-1515. 7. Zobair M. Younossi, et al, Prevalence and predictors of cirrhosis and portal hypertension in the United States, American Association for the Study of Liver Disease, DOI: 10.1097/HEP.0000000000001243. 30% of those
listed for liver transplant will die waiting1 MASH cirrhosis is expected to become the most frequent reason for a liver transplant6 Prevalence increased >2x in the past decade 4 Addressable market in the U.S. Being overweight or
obese Having hypertension, high cholesterol or high triglyceride levels Having type 2 diabetes, insulin resistance or prediabetes 9 ~8.7K Liver transplantations in the U.S.5 100M Americans have fatty liver disease (most don't know
it)1 20M Develop liver fibrosis1 5M Progress to MASH cirrhosis1 3.3M MASH cirrhosis and portal hypertension7 Only curative treatment is liver transplant1 ~8.7K Liver transplantations in the U.S.5
10 3rd Party Market Opportunity Assessment Suggests1 Potential 35-100%
Adoption Rate Limited current treatment options: Cirrhotic management focuses on stabilization and delaying progression Management directed towards comorbidities Highly favorable perception of belapectin indication, MoA and safety by HCPs
Payers believe in the high unmet need in MASH cirrhosis Belapectin is a Novel Therapy with First- and Best-in-Class Potential in MASH Cirrhosis 1. LifeSci Consulting Belapectin Commercial Opportunity Assessment contracted by the
Company. United States Estimates1 A significant unmet need exists for MASH compensated cirrhosis patients with portal hypertension due to disease severity and risk of decompensation $18B 5M 1.7M Patients with compensated MASH cirrhosis
in 2024 Peak belapectin sales in U.S. Patients with compensated cirrhosis and portal hypertension with no varices in 2024
HPVG=hepatic venous pressure gradient. There are no approved therapies to
reverse portal hypertension once it develops in MASH Cirrhosis When to Intervene in Cirrhosis- before its too late! 11 Compensated cirrhosis Decompensated cirrhosis No Portal Hypertension Portal Hypertension Stage 2 Stage 3 and
4 No varices No varices Varices, small to large Varices Bleeding, ascites, encephalopathy HVPG1 mm Hg One year mortality 1-3% One year mortality ~50% 6 >10
Phase 2b Study of Belapectin in Patients with MASH Cirrhosis: GT-026 Trial
12 Placebo n=54 Screen Belapectin 8 mg/kg/LBM Q2W n=54 52 Weeks Belapectin 2 mg/kg/LBM Q2W n=53 Randomize (N=162 1:1:1) Main inclusion criteria MASH cirrhosis (biopsy) Portal Hypertension: HVPG 6 mmHg No cirrhosis
complications No varices/varices (50:50) Primary endpoint Portal pressure (HPVG) change from baseline to Week 54 Secondary endpoints at Week 54 Liver biopsy Varices (esophago-gastric endoscopy) Cirrhosis decompensation HVPG = Hepatic
Venous Pressure Gradient; LBM=lean body mass. 1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45.
Belapectin Impact on HPVG at One Year1,* 13 HVPG = Hepatic Venous Pressure
Gradient; LBM=lean body mass, N.S.=non significant. *ITT with LOCF, ANCOVA with baseline as covariate and treatment as factors, Bonferroni-Holm.1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45. N.S. N.S. Baseline 1 yr Baseline 1
yr Baseline 1 yr Baseline p=0.02 p=0.44 ITT Population Subjects with no varices at baseline 1 yr Baseline Baseline 1 yr
Belapectin Reduces Emergence of Varices in Patients with MASH Cirrhosis1,*
14 Significantly fewer new varices on belapectin vs placebo No patients on 2 mg/kg/LBM developed new varices Belapectin demonstrated efficacy on a clinically-meaningful endpoint where no current therapies exist LBM=lean body mass. *Chi
square 1. Chalasani N, et al. Gastroentrol. 2020;158:1334-45. p=0.02 p=0.12
NAVIGATE Trial Design Placebo n=119 Screen Belapectin 2 mg/kg/LBM
Q2W n=119 78 Weeks Belapectin 4 mg/kg/LBM Q2W n=119 Randomize (N=357 1:1:1) Trial Design 15 Originally the NAVIGATE trial was designed as an adaptive Phase 2b/3 trial for 36-month duration. However, based on FDA feedback, the
Company made the decision to analyze the stage 1 (18 month) as stand-alone clinical trial. LBM- Lean body mass; EGD=Esophagogastroduodenoscopy; 1- Noureddin M, et al. Gastroenterology 2020 8;159(2):422-427 Patient Population MASH cirrhosis
based on Liver Forum Recommended Criteria for Clinical Trials1 Diagnosis of Portal Hypertension as per Baveno VI criteria (via non-invasive markers) No gastroesophageal varices by endoscopy at baseline Assessment of Varices thru central
adjudication of endoscopy videos by multiple blinded reviewers based on standardized protocol.
NAVIGATE Study: Patient Population and Efficacy Endpoints MASH cirrhosis No
varices on EGD CTP Scores <7 Evidence of Portal hypertension: Platelet count <150,000/mm3 Or at least two of the following AST/ALT > 1 Spleen 14 cm Collaterals by imaging Stiffness 20 kPa Development of new varices
(composite strategy) in ITT population Incidence of Varices in per protocol population (Completers) Hepatic decompensation events All-cause mortality Proportion of patients with large varices or red wale sign Varices requiring
treatment MELD 15 Liver transplant Non-invasive biomarkers ALT=alanine aminotransferase ; AST=aspartate transaminase; CTP=Child-Turcotte-Pugh; EGD=Esophagogastroduodenoscopy; MELD=model for end-stage liver disease. *Intercurrent
events include; Liver related clinical events, any AE leading to discontinuation, TIPS Trans-jugular intrahepatic portosystemic shunt; 12-month use of GLP-1 or NSBB ITT- Intent to Treat Key inclusion criteria Primary endpoint Secondary
Key Populations for Assessment of Varices Outcome ITT population- All
randomized subjects minus two subjects who had varices at baseline; Per-Protocol or completer population- All subjects who completed 18 month of therapy and had an EGD at baseline and 18 months Subject were required to complete the study
even after development of varices unless subject dropped out for other reasons Composite Primary end point: Any subject who developed esophageal varices or had an intercurrent event or dropouts without an EGD/intercurrent event Intercurrent
events included; Liver related clinical events, AE leading to discontinuation TIPS-Trans-jugular intrahepatic portosystemic shunt 12-month use of GLP-1 or NSBB 17
NAVIGATE Trial: Baseline Demographics 2014 Galectin Therapeutics | NASDAQ:
GALT Baseline Demographics and Clinical Characteristics (N=355) Placebo (N = 118) Belapectin 2 mg (N = 119) Belapectin 4 mg (N = 118) Mean (Standard Deviation) Mean (Standard Deviation) Mean (Standard Deviation) Age
(years) 60.4 (8.50) 60.6 (8.82) 59.0 (9.14) Gender (female), n 72 (61.0) 75 (63.0) 83 (70.3) Ethnicity (Hispanic), n 34 (28.8) 39 (32.8) 33 (28.0) Race (white), n 104 (88.1) 107 (89.9) 111 (94.1) Weight (kg) 94.2
(21.68) 98.1 (24.30) 94.6 (20.95) BMI (Kg/m2) 33.82 (6.46) 34.88 (6.68) 34.53 (6.22) Hypertension 89 (75.4) 89 (74.8) 82 (69.5) Type 2 Diabetes 80 (67.8) 79 (66.4) 79 (66.9) HbA1C % 6.4 (1.27) 6.3 (1.13) 6.4 (1.09) Alanine
Aminotransferase (ALT), U/L 46.3 (29.92) 38.9 (26.88) 39.7 (20.22) Aspartate Aminotransferase (AST), U/L 46.7 (23.52) 41.8 (24.40) 43.6 (21.90) Platelets (per L) 130.1 (39.66) 127.6 (48.39) 136.4 (53.62) Liver Stiffness
Measurement (kPa) 24.22 (12.17) 24.63 (13.54) 25.67 (13.19) Spleen (cm) 13.79 (2.7) 13.97 (2.6) 13.87 (2.4) MELD Score 7.6 (1.65) 7.9 (2.46) 7.5 (1.55) Child Pugh Score 5.1 (0.29) 5.1 (0.31) 5.0 (0.18) Statins (n) 49
(41.5) 55 (46.2) 47 (39.8) GLP-1 agonist (n) 24 (20.3) 26 (21.8) 27 (22.9) 18
Key points NAVIGATE 18-Month Primary Analyses Result - ITT Population Intent
to Treat (ITT) -All randomized subjects Primary end point composite strategy i.e. new varices and/or intercurrent events or drop out Intercurrent events (ICEs) include; Liver related clinical events, AE leading to discontinuation, TIPS;
12-month use of GLP-1 or NSBB Overall Target Significance level- 2-sided p value of 0.05; p: 0.048, using CMH test, stratified by Type 2 diabetes status at randomization. p 0.139 p 0.552 n = 118 n = 119 n = 118 ITT
Population Number of subjects with new varices Composite Primary Endpoint, ITT (All Randomized) 19
NAVIGATE: Intercurrent Events breakdown by category 2014 Galectin
Therapeutics | NASDAQ: GALT n = 118 Subject % Intercurrent Event Category 20 Key points No subject met intercurrent event category for Trans-jugular intrahepatic portosystemic shunt(TIPS) or 12-month use of non-selective beta-blocker
NSBB ITT Population 6.3% subjects received concomitant NSBB, none for 12 months
NAVIGATE: Significantly Lower Incidence of Varices in Completers at 18 months
2014 Galectin Therapeutics | NASDAQ: GALT N = 97 N = 98 N = 95 n = 94 n =97 n = 96 p=0.04 p=0.13 Number of subjects Subjects with new varices 21 Key points NAVIGATE 18-month Primary Analyses Result; Per protocol population n=
287 Completer/Per Protocol: All ITT subjects who completed 18 months of treatment with an end of treatment (EOT) EDG Overall Target Significance level - 2-sided p value of 0.05; using CMH test, stratified by Type 2 diabetes status at
NAVIGATE: Incidence of Varices by Size at 18-months 2014 Galectin
Therapeutics | NASDAQ: GALT Number of subjects with new varices Subjects with new varices New varices at 18 months in Per Protocol Population 22 Key points Placebo Treatment Group: N = 94 2mg/kg Belapectin Treatment Group: N =
97 4mg/kg Belapectin Treatment Group: N = 96 Varices grade definition Large > 5 mm in diameter, occupying more than 1/3 of esophageal lumen Medium >5 mm in diameter, occupying less than 1/3 of esophageal lumen Small <5 mm in
diameter, minimally elevated above esophageal mucosa. p=0.04
Incidence of New Varices was Significantly Lower in Patients in the U.S.
2014 Galectin Therapeutics | NASDAQ: GALT n=13/62 n=4/60 n=8/64 n=8/32 n=7/37 n=5/ 32 p=0.02 p=0.54 p=0.35 NAVIGATE 18-month; Per protocol population (n=287) p=0.2 23